The following data is part of a premarket notification filed by Trans1, Inc. with the FDA for Trans1lateral Interbody Fusion System.
Device ID | K123997 |
510k Number | K123997 |
Device Name: | TRANS1LATERAL INTERBODY FUSION SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | TRANS1, INC. 301 GOVERNMENT CENTER DR Wilmington, NC 28403 |
Contact | Cheryl L Wagoner |
Correspondent | Cheryl L Wagoner TRANS1, INC. 301 GOVERNMENT CENTER DR Wilmington, NC 28403 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-26 |
Decision Date | 2013-04-01 |
Summary: | summary |